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Bristol-Myers Squibb Pharmaceutical Limited
Watery Lane, Swords, Co. Dublin,
Telephone: 1 800 749 749
Medical Information Direct Line: Freephone: 1 800 749 749
Medical Information e-mail: Medical.information@bms.com
Summary of Product Characteristics last updated on medicines.ie: 01/07/2016
SPC Fungizone 50mg Powder for Sterile Concentrate

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 01/07/2016 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   28-Jun-2016
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Update to section 4.2 was mainly QRD related and re-structuring of text$0Update to section 4.4 was related to addtion of new warning text "Reports of neurological events such as arachnoiditis, myelopathy, paresis and paralysis have been associated with the intrathecal route of administration, see section 4.2 Intrathecal (e.g.coccidioidal meningitis)."$0$0Update to section 4.8 impacted the Undesirable effect table$0$0Other minor QRD changes have taken place throughout the SmPC$0$0$0$0$0$0$0
Updated on 23/06/2014 and displayed until 01/07/2016
Reasons for adding or updating:
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Date of revision of text on the SPC:   20-Jun-2014
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Update to section 4.8 to include the ADR reporting statement.
Updated on 14/01/2014 and displayed until 23/06/2014
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   19-Dec-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
A typo in Section 4.8 was noticed and corrected (hypertension was spelt hyperstension). The same changes from the varaition approved on the 19th December 2013 still apply.
Updated on 03/01/2014 and displayed until 14/01/2014
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   19-Dec-2013
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


This was a grouped application proposes to align the summary of product characteristics (SmPC) to the company core data sheet (CCDS).

Updated on 05/12/2012 and displayed until 03/01/2014
Reasons for adding or updating:
  • Correction of spelling/typing errors
  • Addition of legal category
Date of revision of text on the SPC:   15-Feb-2011
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company
Correction of formatting in sections 4.8 4.9 and 7.
Updated on 18/02/2011 and displayed until 05/12/2012
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   01-Nov-2010
Legal Category:   Product subject to medical prescription which may be renewed (B)

Free-text change information supplied by the pharmaceutical company


 

In Section 6.5, the colour description of the glass vials has changed to: 

Type I clear flint glass vials closed with a grey butyl rubber stopper.  Vials of 50mg.
Updated on 24/07/2008 and displayed until 18/02/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   05/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
 

4.8       Undesirable Effects

 

Addition of heparin (1000 units per infusion), rotation of the injection site, the use of a paediatric scalp-vein needle and alternate-day therapy may lessen the incidence of thrombophlebitis.  Extravasation may cause chemical irritation.  The adverse reactions that are most commonly observed are: fever (sometimes with shaking chills), headache, anorexia, weight loss, nausea and vomiting, malaise, muscle and joint pains, dyspepsia, cramping epigastric pain, diarrhoea, local venous pain at the injection site with phlebitis and thrombophlebitis, normochromic normocytic anaemia and hypokalaemia.  Abnormal renal function (including renal impairment, renal insufficiency, acute renal failure and nephrogenic diabetes insipidus) including hypokalaemia, azotaemia, hyposthenuria, renal tubular acidosis or nephrocalcinosis, is also commonly observed and usually improves upon interruption of therapy; however, some permanent impairment often occurs, especially in those patients receiving large amounts (over 5g) of amphotericin.
Updated on 01/06/2006 and displayed until 24/07/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Updated on 18/07/2005 and displayed until 01/06/2006
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.3 - Shelf life
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Updated on 20/08/2003 and displayed until 18/07/2005
Reasons for adding or updating:
  • New SPC for medicines.ie
Updated on 18/06/2003 and displayed until 20/08/2003
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Amphotericin B